Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour

Giant Cell Tumors Clinical Trial

— DENO  

Official title:

Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542524
• Other study ID #: 8699
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult. These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare. In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
• Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

Exclusion criteria:

• Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes
• Pathology finally labeled other than giant cell tumour.
• Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.
• Absence of oral follow-up element.

Related Conditions & MeSH terms

• Giant Cell Tumors

Locations

Country	Name	City	State
France	Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)		Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined